PDA Letter Article

Not So Different After All

by Rebecca Stauffer, PDA

Rick Rhoads

Compounding Pharmacist Learns about Aseptic GMP in PDA Course

Earlier this year, Rick Rhoads, PharmD, a pharmacist with a compounding pharmacy attended PDA’s “Aseptic Processing Training Program.” Below he shares his experience with the PDA Letter and what he thinks compounding pharmacists can gain from the course.

PDA Letter: Tell us a little bit about your background.

Rhoads: For the past 11 years I have worked as a compounding pharmacist at the University Compounding Pharmacy, where we provide custom sterile and nonsterile medications directly to patients with a patient-specific prescription. Working in a compounding pharmacy has provided me with many opportunities to gain a wide range of experiences. In the past, I have worked in sterile processing, facility design, quality management, personnel training, regulatory compliance and other areas. I currently serve as the Director of Compounding, and am responsible for regulatory compliance, development of the quality system and leadership development. Recent growth has allowed us to differentiate our 75 employees into specialized teams to respond to changes in our industry. In many ways, the regulatory landscape is becoming more complex; traditionally, pharmacy compounding has been regulated by the states, meaning each state has a different set of regulations. But in the last five years, these laws have changed due to the compounding tragedy at the New England Compounding Center. The U.S. FDA also began regularly inspecting compounding pharmacies about five years ago. We are just learning what FDA oversight of compounding looks like, and how to remain compliant. This makes it even more complicated for our pharmacy because we have licenses in 41 different states.

PDA Letter: As a pharmacy compounder, what drew you to PDA, and by extension, the “Aseptic Processing Training Program?”

Rhoads: In 2015, our pharmacy received its first FDA inspection, for which I was completely under-prepared. My focus was complying with USP <797> Pharmaceutical Compounding – Sterile Preparations, the USP chapter for sterile compounding. The FDA investigator, however, approached it from a cGMP perspective. The requirements, and even terminology used in cGMP are different than that used in compounding. By the end of the inspection, I was convinced that learning cGMPs from an aseptic manufacturing point of view was important, both from a quality and a regulatory standpoint. Since 2016, I have attended two classes at PDA and each one provided a new perspective for me. My first aseptic training was the “Recommended Practices for Manual Aseptic Processing.” Subsequently, I attended the two-week “Aseptic Processing Training Program.” David Matsuhiro and the rest of the instructors provided a wealth of information from a very practical point of view.

PDA Letter: From your experience, what are the main differences between pharmacy compounding and GMP? How about similarities?

Rhoads: Aseptic manufacturing and compounding pharmacies serve very different roles in healthcare. Traditional compounders prepare small batches of medication that are dispensed directly to patients. These medications are not FDA approved. Whether it is an IV in a hospital or a custom capsule in a retail pharmacy, the finished dosage form is not available from a manufacturer. And due to the critical nature and limited availability, compounders must supply these medications in a timely manner. In many cases, it is crucial that the patient receives therapy immediately. Quality decisions are very different between the two industries as well. The risk associated with compounding a drug used by one patient over ten days is much less than manufacturing 50,000 vials for distribution over a year. This leads compounders to rely more heavily on quality standards while manufacturers rely on quality systems. There are limits, however, to this analogy. Many pharmacies now make large batches of medication, which requires a better quality system. In my opinion, the challenge of compounders is to apply the strict control of a pharmaceutical quality system onto a pharmacy operation to meet the diverse, critical needs of patients.

As far as similarities, pharmaceutical manufacturing initially emerged from pharmacy compounding. The goal of both industries is to provide safe and effective medications that treat disease and promote health. The safety of medications used by the public is imperative regardless of whether they were manufactured or compounded. Many of the same principles are translatable between aseptic manufacturing and sterile compounding. Whether it is facility design, aseptic technique, gowning, or environmental monitoring, both industries are heavily focused on these aspects of their operation. Still, there is definitely a much higher standard in manufacturing. Manufacturing also has a more sophisticated understanding of how each of these elements fits into systems. In addition, the validation work is more robust.

PDA Letter: What were the top three things you learned from the course?

Rhoads: The first and most important lesson for our pharmacy was the pre-eminence of airflow in an aseptic operation. The airflow must dictate, on a minute level, every process involved in sterile compounding. This was not a completely new concept, but it was presented in a way that displayed the impact on the final product. For pharmacists, we typically perform aseptic manipulations in a unidirectional airflow device, like an LAFW or BSC. The setup and manipulations are performed in the same direct compounding area. This makes airflow principles for process design even more critical.

The next important concept was the lifecycle approach to validation. Intense validation work is not typically encountered in a compounding pharmacy because it is difficult to do this with thousands of different formulas. But one can adopt the concepts outlined and apply them to areas of high volume and high risk.

Finally, the important role of risk management in quality decisions is a concept we can better integrate in the pharmacy. Hal Baseman presented several comprehensive approaches to quality risk management. Compounders often make risk-based decisions without structured methods to evaluate them. To improve our quality risk management, we plan on utilizing a simplified QRM model presented by Hal.

PDA Letter: How will this course help you going forward?

Rhoads: During the course, it was easy to get overloaded with material. I wrote down lists of helpful information, but then distilled my notes down to large and impactful concepts. These concepts provide somewhat of a guiding light for improving quality in the long run. As our pharmacy continues to grow, it becomes imperative to learn from the manufacturing industry. It is my goal to bring the pharmacy as close to cGMP as possible, while maintaining the ability to serve the critical needs of patients. There is no doubt that the “Aseptic Processing Training Program” will help in this regard.

PDA Letter: How could other compounders benefit from joining PDA?

Rhoads:There is no better way to improve at something than by learning from those at a higher level than you. Out of necessity, cGMP manufacturers have better “built in” quality because their impact is so much greater. Compounders do not need to reinvent the wheel. The experts at PDA provide very useful information that is beneficial for compounding pharmacies wanting to take their operation to the next level. Joining and receiving training at PDA can be a good supplement for any compounding pharmacy serious about improving quality.